This invention relates to the reconstitution (rehydration) of human bone and other related allograft tissue and more particularly to a kit and process for the reconstitution of freeze-dried human bone and musculoskeletal allograft tissue.
The concept and procedure of human organ transplants has gained wide acceptance in the medical community as a viable manner to treat human disorders which would otherwise be untreatable. A currently expanding medical procedure involves the transplanting of human allograft bone and related allograft tissue, extracted from recently deceased human cadavers, to recipients in need of such bone and tissue.
In order to provide allograft bone and related tissue which is suitable for transplanting, such bone and tissue must be recovered in operating rooms under sterile conditions and moreover must be processed and stored under specific aseptic guidelines. In order to preserve the biologic and biomechanical integrity of the bone or tissue, the bone or tissue is typically freeze-dried and stored as such. However, prior to its intended use as a transplant organ, freeze-dried human bone or tissue requires reconstitution under aseptic/sterile conditions.
In the past, reconstitution procedures involved a laborious and uncontrolled multi-step process to ensure that the bone or tissue remains sterile during the procedure. Generally, past procedures require the preparation of a reconstitution solution comprised of sterile water to which antibiotics are added as a preservative. Antibiotic preservative is required since typically several hours of reconstitution may be necessary to obtain bone or tissue suitably pliable for pre-operative shaping and incubation of the bone or tissue in sterile water alone cannot be expected to reliably maintain sterility of the bone or tissue over the entire reconstitution period.
In the past, the selection of the types and quantities of antibiotics employed has been left, for example, to the surgical team. In some instances, this selection may not be optimal for the maintenance of sterility and/or protection of the transplant recipient. Furthermore, it may be necessary to transfer the bone or tissue and/or reconstitution medium to another container of variable suitability for the period of reconstitution As a final step, the bone or tissue is rinsed with sterile water to remove any traces of antibiotic just prior to transplantation.
It is, therefore, readily apparent that past procedures for the reconstitution of bone or other musculoskeletal allograft tissue lack the convenience and uniformity to assure that sterile technique and recipient safety are being maintained. Therefore, an improved reconstitution procedure is highly desired.